Kornimate/medical-research-clean huggingface dataset:
induction chemotherapy combined with camrelizumab in locoregionally advanced hypopharyngeal cancer

Conditions: Hypopharyngeal Cancer; Immunotherapy; Induction Chemotherapy

Summary: the study is a single center phase ii trial. the purpose is to investigate both the efficacy and safety of chemotherapy combined with anti-pd-1 antibody followed by chemoradiotherapy in locoregionally advanced hypopharyngeal cancer.


Eligibility criteria:
inclusion criteria: 1. age: 18-75 years; 2. hypopharyngeal squamous cell carcinoma confirmed by histopathology; 3. no distant metastases, stage iii-iv (according to the 8th uicc/ajcc tnm staging system ); 4. at least 1 measurable lesion (according to recist1.1), and the lesion has not been treated; 5. provide tissues for biomarker analysis; 6. ecog ps 0-1; 7. adequate hematologic, hepatic and renal function: anc ≥ 1.5x10\^9/l, hb ≥ 90g/l, plt ≥ 100 x10\^9/l, albumin ≥ 28g/l, total bilirubin \< 1.5×uln at diagnosis or after biliary drainage, alt and ast \< 5×uln, bun、crea\<1.5×uln, creatinine clearance rate ≥ 45ml/min; 8. contraception during the study; 9. at least 12 weeks of life expectancy; 10. willing to join the study and sign informed consent. exclusion criteria: 1. allergic to any component of carrelizumab, cisplatin and other platinum drugs; 2. have received anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137 or ctla-4 antibody therapy in the past; 3. received biological treatment or participated in clinical trial of other drugs or devices within 4 weeks before enrollment; 4. have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer; 5. have corticosteroids (\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies, nausea or vomiting; 6. uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above nyha ii, unstable angina, myocardial infarction within 1 year； 7. have severe infections (ctcae\> grade 2) occurred within 4 weeks before the first use of the study drug; 8. have active autoimmune diseases, autoimmune diseases, but not including autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes with stable doses of insulin; vitiligo or cured childhood asthma/allergies; 9. a history of immunodeficiency, including a positive hiv test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 10. a history of interstitial lung disease (excluding radiation pneumonia that has not been treated with hormones) and a history of non-infectious pneumonia; 11. active tuberculosis, having antituberculosis therapy at present or within 1 year; 12. have active hepatitis b (hbv dna ≥2000 iu/ml or 10\~4 copies/ml) and hepatitis c; 13. have other uncontrollable comorbidities; 14. knowing a history of psychotropic drug abuse, alcohol or drug abuse; 15. pregnant or breastfeeding, or expect to become pregnant during the clinical trial period.
the role of acute combined ppar alpha and gamma stimulation on insulin action in humans

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to investigate the acute effects of the thiazolidinedione agent pioglitazone (which has combined ppar alpha and gamma stimulation) on insulin's ability to suppress glucose production, stimulated glucose uptake, and impact a number of other metabolically important endpoints, including production of adiponectin (a protein hormone which regulates sugar levels and fatty acid breakdown) in subjects with type 2 diabetes.

participants in this study were given a supply of either pioglitazone (a medication used to treat diabetes) or matched placebo for a duration of 10 days or 21 days. changes to the body's response to insulin in the liver and in peripheral tissues (eg, muscle and fat) will be measured using a procedure called a pancreatic clamp. during the clamp procedure, glucose (a sugar) and insulin were infused with an intravenous catheter, and blood samples were collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. small amounts of muscle and fat tissue were also taken during this study to measure changes in gene expression after taking the medication/placebo.

Eligibility criteria:
inclusion criteria: • individuals with type 2 diabetes exclusion criteria: * individuals with bleeding disorders including gastrointestinal reflux disease (gerd), peptic ulcer disease (pud), any gastrointestinal (gi) bleeding * high blood pressure * history of coronary artery disease or chest pain on exertion

Keywords: type 2 diabetes mellitus
clinical investigation of two different wound dressings

Conditions: Wounds and Injuries

Summary: the primary objective of this investigation is to evaluate changes on peri-wound skin from baseline to termination when using two different wound dressings the secondary objectives are to evaluate pain before, during, and after dressing removal from baseline to termination

a prospective randomized clinical investigation will be conducted at two sites in sweden. male or female, 18 years or older with following wound types: * traumatic, surgical or dehisced wounds, * venous leg ulcer or pressure ulcer will be included into the clinical investigation. 32 evaluated subjects (i:e 16 subjects per arm) will be followed during maximum three weeks. the treatment arm (either silicon adhesive dressing or acrylic adhesive dressing). patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of skin (normal/dry/flaky/oily/moist) and age. eligible patients will be randomized to receive either silicon adhesive dressing or acrylic adhesive dressing in a ratio of 1:1 provided.

Eligibility criteria:
inclusion criteria: 1. traumatic, surgical or dehisced wounds, venous leg ulcer, diabetic foot ulcer or pressure ulcer indicated for treatment with npwt therapy 2. in case of multiple wounds the target wound must be ≥10 cm distant from other wounds. selection of the target wound is according to the investigator's preference. 3. peri-wound skin assessable and 5 cm of peri-wound skin present around the wound 4. male or female, 18 years of age and above 5. signed informed consent exclusion criteria: 1. dressing sizes does not fit the target wound 2. unexplored blind tunnels or non-enteric fistula 3. untreated osteomyelitis 4. malignant wounds 5. subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. 6. wounds with necrotic tissue or eschar (if not adequately debrided) 7. significantly bleeding wounds, as judged by the investigator 8. subject not suitable for the investigation according to the investigator's judgment 9. subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator 10. known allergy/hypersensitivity to any of the components included into the investigation.
the oral microbiome in oscc

Conditions: Oral Cancer

Summary: previous work by a number of scientific teams has revealed that the types of bacteria that colonize the mouth differ between health and pre-cancerous or cancerous oral lesions. the purpose of this study is to investigate the extent of these changes and to correlate the changes with alterations in the activities of the host's own oral tissues. in doing so, we believe we can gain a better understanding of how particular bacterial species, or consortia of species, can result in an individual having an increased risk of the most common type of oral cancer -- oral squamous cell carcinoma. this knowledge may also lead to the identification of salivary biomarkers that can be used for clinical evaluation or screening. in addition, we seek to determine the extent to which a probiotic regimen can help prevent or rectify the disease-related changes in the types of bacterial colonizing the mouth. the microbiome in health, pre-cancerous lesions, and cancerous lesions will be determined from remnant microbial dna in banked tissue samples. the effects of probiotics on the oral microbiome will be determined from dna collected from swabs of oral tissue at baseline and then after 3 to 6 months of probiotic usage.


Eligibility criteria:
inclusion criteria: 1. adults (21-70 years old) who have been diagnosed with oral dysplasia or that have been treatment-planned as wait and watch or 2. adults (21-70 years old) or who have been diagnosed with oral squamous cell carcinoma, or matched healthy controls free of any oral lesions exclusion criteria: 1. adults who have had a course of antibiotics that was completed less than 3 months prior to the study; 2. adults with any immunosuppressive condition or medication that would put the subject at risk of consuming daily probiotics; 3. adults who regularly use probiotic dietary supplements 4. adults that have alcohol/tobacco use history that does not match study population - this if for the healthy controls arm only.
a study of ro5083945 in combination with folfiri versus folfiri plus cetuximab or folfiri alone as second line treatment in patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this randomized, multicenter, open label study will evaluate the safety and efficacy of ro5083945 in combination with folfiri as compared to folfiri plus cetuximab or folfiri alone as second line treatment in patients with metastatic colorectal cancer. patients will be randomized to receive ro5083945 (1400 mg intravenously on day 1 and day 8 and every 2 weeks thereafter) plus folfiri standard iv chemotherapy or folfiri plus cetuximab (400 mg/m2 iv on day 1 followed by 250 mg/m2 iv every week) or folfiri alone. anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * carcinoma of the colon and/or rectum * disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease * ecog performance status 0-1 * adequate hematological, renal and liver function exclusion criteria: * prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (egfr) * prior treatment with irinotecan * radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief) * cns metastasis * history of or active autoimmune disorders/conditions
investigation of the effects of kegel exercises on vaginal flatus among postpartum women

Conditions: Pelvic Floor Awareness; Postpartum; Postpartum Pelvic Floor Function and Symptoms; Flatus

Summary: title: investigation of the effects of kegel exercises on vaginal flatus among postpartum women brief summary: this study aims to evaluate the effectiveness of kegel exercises in reducing vaginal flatus among postpartum women. vaginal flatus, the involuntary passage of air through the vagina, is a common but often underreported pelvic floor dysfunction that can affect women's quality of life. a total of 40 postpartum women were randomly assigned to an experimental group (performing kegel exercises) or a control group (no intervention). the experimental group performed kegel exercises three times daily in different positions for six weeks. vaginal flatus frequency and bother scores were assessed using a validated questionnaire, and sexual quality of life was evaluated with the pelvic organ prolapse/urinary incontinence sexual questionnaire (pisq-12).

this study is a randomized controlled trial designed to assess the effectiveness of kegel exercises in reducing vaginal flatus among postpartum women. vaginal flatus, the involuntary passage of air through the vagina, is a common but often overlooked pelvic floor dysfunction that can negatively impact women's quality of life. a total of 40 postpartum women were recruited and randomly assigned to either the experimental group, which performed kegel exercises, or the control group, which received no intervention. participants in the experimental group were instructed to perform kegel exercises three times daily in different positions (supine, sitting, and standing) over six weeks. the intervention focused on strengthening the pelvic floor muscles through a combination of fast and slow contractions targeting both type i and type ii muscle fibers. the primary outcome measures included vaginal flatus frequency and bother scores, which were assessed using a validated questionnaire before and after the intervention. additionally, sexual quality of life was evaluated using the pelvic organ prolapse/urinary incontinence sexual questionnaire (pisq-12).

Eligibility criteria:
inclusion criteria: * being between the ages of 20-50, * being postpartum at least 6 weeks after the last birth, * having a complaint of vaginal flatus, and being willing to exercise exclusion criteria: * being over four months postpartum, * current pregnancy, * presence of pelvic infection, * inability to indicate whether there is vaginal flatus, * the presence of gynecological cancer.

Keywords: kegel exercises pelvic floor exercises postpartum period vaginal gas vaginal flatus
artificial intelligence-assisted insulin system in type 2 diabetes in general wards

Conditions: Diabetes Type 2

Summary: our study was a single-blind, randomised, controlled, multicentre study. the study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. the effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.

our study was a single-blind, randomised, controlled, multicentre study. the study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. the effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus \> 3 months * age≥18 years old * receiving glucose-lowering therapy for at least 90 days * blood glucose:7.8-22.2 mmol/l * length of proposed hospitalisation ≥5 days exclusion criteria: * type 1 diabetes mellitus, other special types of diabetes mellitus. * bg\>22.2 mmol/l, or acute complications of diabetes, such as diabetic ketoacidosis, diabetic hyperosmolar state. * history of severe or repeated hypoglycaemia * bmi≥45 kg/m2 * pregnant and lactating women * clinically relevant liver disease (established cirrhosis and portal hypertension); * presence of severe renal disease (serum creatinine ≥3.0 mg/dl or estimated glomerular filtration rate \<30 ml/min/1.73 m2); * severe cardiac insufficiency; * patients on cortisol-based hormone therapy (equivalent to a prednisone dose \>5 mg/day); * psychiatric abnormalities or impaired cognitive function; * patients with severe oedema, infection, or peripheral blood circulation disorder; * patients with severe illness or patients to be transferred to icu for treatment; * surgery of the heart or abdomen that may have a significant impact on the test is planned during hospitalisation.

Keywords: diabetes insulin
analgesic effectiveness of peng block in programmed hip arthroplasty surgery

Conditions: Postoperative Pain

Summary: the intra- and peri-articular infiltration of local anaesthetics realized at the end of total hip arthroplasty surgeries is an effective analgesic technique, but it can be insufficient to manage the possibly intense postoperative pain. regional anaesthesia (ra) like the recently described pericapsular nerve group (peng) block could provide additional analgesic benefit in this setting. investigators main objective is to demonstrate the analgesic benefits (postoperative pain score and morphine consumption) of the peng block when added to intra- and peri-articular infiltration of local anaesthetic following total hip arthroplasty. investigators make the assumption that i) the peng bloc could reduce the postoperative 24 first hours morphine consumption by 30%, ii) the peng block could spare the motor function of the quadriceps and adductor muscles, and iii) the peng bloc could be well tolerated allowing a high level of patient satisfaction.

a recent study has revealed a region of pericapsular terminal branches of the femoral nerve and the obturator nerve accessible to ultrasound-guided regional anaesthesia. this technique, also called the peng block, has recently been described with a substantial benefit on pain at rest and induced by mobilization in cases series of patients undergoing hip fracture surgery. to investigators knowledge, no randomized data concerning the analgesic efficacy of the peng block has been published in the setting of elective total hip arthroplasty. the peng block would allow a significant analgesic contribution when added to intra- and peri-articular infiltration of local anaesthetics while being well tolerated with few undesirable effects. moreover, the peng block could spare the motor function of the quadriceps and adductor muscles allowing enhanced recovery after surgery

Eligibility criteria:
inclusion criteria: * scheduled for total hip arthroplasty surgery under general anaesthesia * affiliated of a social security scheme * having signed the written informed consent exclusion criteria: * total hip arthroplasty revision surgery * refusal of the patient to participate * existence of major spontaneous or acquired haemostasis disorders * infection at the puncture site * allergy to local anaesthetics * pregnancy or breast-feeding * patients under the protection of adults (guardianship, curatorship or protection of justice) * patients whose cognitive state does not allow assessment by the scales used.

Keywords: total hip arthroplasty peng bloc local anaesthetics infiltration postoperative pain
effects of sleep deprivation on blood hormones and inflammatory status after exercise induced-muscle damage

Conditions: Sleep; Sleep Deprivation

Summary: the aims of this study are examine the effects of sleep deprivation in muscle recovery after a maximum eccentric resistance exercise session performed on an isokinetic dynamometer (24 series of 10 repetitions). the sample will consist of 10 men, sedentary, clinically healthy, aged between 20 and 31 years old. two experimental groups will be developed: exe-sleep, in which subjects will perform the exercise protocol (\~18:00-19:00) and will be subject to normal period of sleep for 3 nights; exe-total, in which subjects will perform the same exercise protocol and will be sleep deprived for 60 hours, followed by one night of sleep rebound.

the blood parameters analyzed will be: * creatine kinase and myoglobin: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol. * total and free testosterone, igf-1, and cortisol: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol. moreover, from 19:00 of the second day to 19:00 of the third day it will be collected blood samples every 2 hours. * gh: during the second night, gh will be evaluated every 1 hour, from 23:00 to 07:00. * tnf-alfa, il-6, il-1 beta, il-10, and il-1ra: before, immediately after, and 2 hour after exercise, as well every 4 hours from 19:00 of the second day to 19:00 of the third day. it will be evaluated isometric strength every 12 hours, as well visual analog scale of pain.

Eligibility criteria:
inclusion criteria: * healthy subjects * sedentary * sleep duration between 6-8 hours peer night exclusion criteria: * smokers * use vitamin supplements, like c and e * drink two doses of alcohol/day or \> 4 doses in one occasion * use of anti-inflammatory drugs * antilipidemic drugs * anemia * muscle or joint diseases * cardiovascular diseases * diabetes * renal diseases * sleep disturbances * breathing disorders
phase iii randomized study of lucinactant in full term newborn infants with meconium aspiration syndrome

Conditions: Meconium Aspiration

Summary: objectives: evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (bal) in the treatment of meconium aspiration syndrome (mas) in newborn infants.

protocol outline: this is a randomized, multicenter study. patients are randomized to one of two treatment arms. arm i: patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. treatment repeats when patient stabilizes or every 15 minutes for 2 courses. arm ii: patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization. patients are followed for 12 months.

Eligibility criteria:
inclusion criteria: * diagnosis of meconium aspiration syndrome (mas) * continuous mechanical ventilation (cmv) at time of entry * enrollment within 48 hours of birth * gestational age of ≥ 37 weeks * oxygenation index of ≥ 5 and ≤ 30 * written informed consent signed and dated by the infant's parent(s) or legal guardian(s) exclusion criteria: * congenital anomalies likely to affect any primary or secondary endpoints * uncontrollable air leaks * hydrops fetalis * rupture ≥ 3 weeks of the fetal membranes * evidence of overwhelming bacterial infection at time of randomization * markedly labile persistent pulmonary hypertension at time of randomization * profound neurologic manifestations * sustained postductal spo₂of \< 87% for ≥ 15 minutes at an fio₂of 1.00

Keywords: cardiovascular and respiratory diseases meconium aspiration syndrome rare disease